EP2344034B1 - Überwachung von patienten mit akutem schlaganfall - Google Patents

Überwachung von patienten mit akutem schlaganfall Download PDF

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Publication number
EP2344034B1
EP2344034B1 EP09745115.7A EP09745115A EP2344034B1 EP 2344034 B1 EP2344034 B1 EP 2344034B1 EP 09745115 A EP09745115 A EP 09745115A EP 2344034 B1 EP2344034 B1 EP 2344034B1
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Prior art keywords
signal
head
patient
signals
measures
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English (en)
French (fr)
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EP2344034A2 (de
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Ben Zion Poupko
Alon Rappaport
Shlomi Ben-Ari
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Orsan Medical Technologies Ltd
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Orsan Medical Technologies Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/026—Measuring blood flow
    • A61B5/0261—Measuring blood flow using optical means, e.g. infrared light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/02028—Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/026—Measuring blood flow
    • A61B5/0295—Measuring blood flow using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4058—Detecting, measuring or recording for evaluating the nervous system for evaluating the central nervous system
    • A61B5/4064—Evaluating the brain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6814—Head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2505/00—Evaluating, monitoring or diagnosing in the context of a particular type of medical care
    • A61B2505/01—Emergency care
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0535—Impedance plethysmography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7239—Details of waveform analysis using differentiation including higher order derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7242—Details of waveform analysis using integration

Definitions

  • This invention relates to a system and method for monitoring an acute stroke patient .
  • the present invention in some embodiments thereof, relates to a method of monitoring acute stroke patients using impedance plethysmography (IPG) and/or photoplethysmography (PPG) and, more particularly, but not exclusively, to monitoring ischemic stroke patients and sub-arachnoid hemorrhage (SAH) patients for significant changes in cerebral hemodynamic parameters.
  • IPG impedance plethysmography
  • PPG photoplethysmography
  • SAH sub-arachnoid hemorrhage
  • a number of cerebral hemodynamic parameters may be clinically useful for diagnosing strokes, trauma, and other conditions that can affect the functioning of the cerebrovascular system. These parameters include regional cerebral blood volume, cerebral blood flow, cerebral perfusion pressure, mean transit time, time to peak, and intracranial pressure. Many methods that are used to measure these parameters, while giving accurate results, are not practical to use for continuous monitoring, or for initial diagnosis outside a hospital setting, because they are invasive, or because they require expensive and/or non-portable equipment. Such methods include inserting a probe into the cerebrospinal fluid or into an artery, computed tomography (CT) perfusion computed tomography (PCT), positron emission tomography (PET), magnetic resonance imaging (MRI), and transcranial Doppler ultrasound (TCD).
  • CT computed tomography
  • PCT computed tomography
  • PET positron emission tomography
  • MRI magnetic resonance imaging
  • TCD transcranial Doppler ultrasound
  • perfusion computed tomography for finding cerebral hemodynamic parameters, and the use of these parameters in evaluating and choosing courses of treatment for stroke patients, is described by Christian Baumgartner et al, "Functional Cluster Analysis of CT Perfusion Maps: A New Tool for Diagnosis of Acute Strokes," J. of Digital Imaging 18, 219-226 (2005 ); by Roland Bruening, Axel Kuettner and Thomas Flohr, Protocols for Multislice CT (Springer, 2005), especially on page 96 ; by Ellen G.
  • a tourniquet was placed around the head to temporarily stop the scalp blood flow, and then released, in order to determine how much of the measured blood flow was due to scalp blood flow, and how much was due to intracranial blood flow.
  • the scalp blood flow was considered to be completely cut off when there was no detectable variation in the signal from a PPG sensor at the cardiac frequency.
  • Rheoencephalography is a technique that uses bio-impendance measurements of the head to obtain information on about cerebral blood circulation and circulatory problems.
  • changes in impedance Z across the head, for a particular arrangement of electrodes are measured as a function of time t over a cardiac cycle, and sometimes over a breathing cycle, due to changes in the volume and distribution of blood in the head.
  • REG is commonly used to measure or diagnose problems with circulatory resistance, and problems with arterial elasticity.
  • G. Bonmassar and S. Iwaki "The Shape of Electrical Impedance Spectrosopy (EIS) is altered in Stroke Patients," Proceedings of the 26th Annual Conference of IEEE EMBS, San Francisco, CA, USA, September 1-5, 2004 , describes a system that uses electrical impedance to measure an asymmetry in the distribution of cerebral spinal fluid that is present in stroke patients, but not in healthy volunteers.
  • the system uses 10 electrodes placed symmetrically around the subject's head, and passes white noise current at 0 to 25 kHz between any selected pair of electrodes, while measuring the potentials at all the electrodes.
  • the system was found to work best if current was passed between the front and back of the head, but the paper also describes passing current between symmetrically placed electrodes on the left and right sides of the head.
  • WO 02/071923 to Bridger et al describes measuring and analyzing pulse waveforms in the head obtained from acoustic signals. Head trauma patients, and to a lesser extent stroke patients, are found to have differences from normal subjects. Trauma and stroke patients are found to have higher amplitudes at harmonics of the heart rate, at 5 to 10 Hz, than normal subjects do.
  • Additional background art includes WO 02/087410 to Naisberg et al ; Kidwell CS et al, Comparison of MRI and CT for detection of acute intracerebral hemorrhage. JAMA; 2004: 292: 1823-1830 ; Horowitz SH et al, Computed tomographic-angiographic findings within the first 5 hours of cerebral infarction, Stroke; 1991: 22 1245-1253 ; The ATLANTIS, ECASS, and NINDS rt-PA study group investigators, Association of outcome with early stroke treatment: Pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials, Lancet; 363: 768-774 ; Albers G et al, Antithrombotic and thrombolytic therapy for ischemic stroke: The seventh ACCP conference on antithrombotic and thrombolytic therapy, Chest 2004; 126: 483-512 ; Kohrmann M et a,.
  • US 2008/200787 A1 there is disclosed a system for monitoring an acute stroke patient according to the preamble of claim 1.
  • US 2008/200787 A1 describes a system and method of estimating blood flow in a brain, comprising causing currents to flow inside the head by producing electric fields inside the head, measuring at least changes in the electric fields and the currents, and estimating changes in the blood volume of the head, using the measurements of the electric fields and the currents, where the current are produced in children or using electrodes at or near holes in the skull.
  • US2008/004904 describes a medical system including a network, one or more medical data collection appliances coupled to the network, each appliance transmitting data conforming to an interoperable format, and a server coupled to the network to store data for each individual in accordance with the interoperable format.
  • RU 2141249 describes a method for diagnosing and predicting hypertension disease in patients before thirty.
  • US2007/287899 describes a method of estimating at least one intracranial hemodynamic parameter in a subject, the method comprising: obtaining data of changes in electrical impedance across the subject's head as a function of time, analyzing the data, and estimating one or more of intracranial pressure, cerebral blood volume, and a factor related to at least one of cerebral perfusion pressure and a mean transit time through cerebral capillaries, DIE 100 61 189 A1 describes and system and method for continuous determination of the arterial blood pressure uses the pulse transition time (PTT) in which the time of pulse arrival at two different body points is measured and then the difference between the two determined, from which a value for blood pressure is determined, each sensor having two electrodes that measure the impedance of the body region and the mean arterial blood pressure from the corresponding PTT.
  • PTT pulse transition time
  • the system for monitoring an acute stroke patient of the invention is characterized by the features claimed in the characterizing part of claim 1, and the invention provides a method of monitoring an acute stroke patient according to claim 26.
  • An aspect of some embodiments of the invention concerns a method of continuously or frequently monitoring acute stroke patients, using IPG and/or PPG, to estimate cerebral hemodynamic parameters, and to detect changes in these parameters that might require immediate medical intervention.
  • Implementation of the method and/or system of embodiments of the invention can involve performing or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of embodiments of the method and/or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware or by a combination thereof using an operating system.
  • a data processor such as a computing platform for executing a plurality of instructions.
  • the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, a magnetic hard-disk and/or removable media, for storing instructions and/or data.
  • a network connection is provided as well.
  • a display and/or a user input device such as a keyboard or mouse are optionally provided as well.
  • the present invention in some embodiments thereof, relates to a method of monitoring acute stroke patients using impedance plethysmography (IPG) and/or photoplethysmography (IPG) and, more particularly, but not exclusively, to monitoring ischemic stroke patients and sub-arachnoid hemorrhage (SAH) patients for significant changes in cerebral hemodynamic parameters.
  • IPG impedance plethysmography
  • IPG photoplethysmography
  • SAH sub-arachnoid hemorrhage
  • An aspect of some embodiments of the invention concerns a method of monitoring an acute stroke patient using impedance plethysmography (IPG) and/or photoplethysmography (PPG), to detect significant changes in cerebral hemodynamic parameters that might require medical intervention, and to alert medical personnel when such changes are detected.
  • the patient is monitored continuously, or at least at frequent intervals, for example data is obtained at least once an hour, or at least twice an hour, or at least once every 10 minutes, or every 5 minutes, or every minute. Monitoring at least once an hour may allow medical intervention to be performed successfully, even with a few unsuccessful attempts, within the typical time window of 3 hours before penumbral brain tissue is permanently damaged, and more frequent monitoring is inexpensive and improves the safety margin.
  • the duration of monitoring is at least six hours, or at least 12 hours, or at least 24 hours, or at least 48 hours. Monitoring for these durations covers the periods when patients are most likely to develop complications, following an initial stroke, or following thrombolytic therapy or endovascular procedures for treating a stroke. The longer the time, the less likely complications are to develop.
  • Continuous monitoring means that once enough IPG and/or PPG data has been accumulated to analyze in order to estimate the cerebral hemodynamic parameters, for example several cardiac cycles worth of data, more data begins to be accumulated without interruption, in order to make the next estimate of the cerebral hemodynamic parameters.
  • continuous or frequent monitoring is made practical by the non-invasive nature, lack of ionizing radiation, relatively small size, and/or relatively low cost of the equipment for IPG and PPG measurements, in contrast to prior art methods of measuring cerebral hemodynamic parameters, such as perfusion CT and perfusion MRI, which are not suitable to use for continuous or very frequent monitoring.
  • the timely medical intervention for example within an hour or less, made possible by such continuous or frequent monitoring can be critical to preventing or minimizing brain damage in the patient.
  • the patient may be an ischemic stroke patient, and a change in cerebral hemodynamic parameters may indicate a hemorrhagic transformation on the ischemia, which is a common complication especially if the patient has received thrombolytic therapy.
  • ⁇ ischemia or edema
  • high blood pressure which can increase the risk of cerebral hemorrhage.
  • the patient is a sub-archnoid hemorrhage (SAH) patient, and a change in cerebral hemodynamic parameters may indicate vasospasm, which is a major cause of mortality and morbidity in SAH patients.
  • SAH sub-archnoid hemorrhage
  • values of one or more standard cerebral hemodynamic parameters in clinical use such as cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit (MTT), and time to peak (TTP), are estimated from IPG and/or PPG signals, and medical personnel are alerted if one or a combination of these standard parameters changes, or fails to change when it was expected to, in a way that indicates medical intervention is needed.
  • a condition for alerting medical personnel is formulated directly in terms of characteristics of the IPG and/or PPG signals. In either case, this is referred to herein as alerting medical personnel in response to changes in one or more measures of cerebral hemodynamics.
  • a variety of methods of analyzing IPG and PPG signals may optionally be used to obtain estimate standard parameters or to obtain other measures of cerebral hemodynamics.
  • the measures depend on the behavior of the signal as a function of phase of the cardiac cycle, although measures based on behavior over longer time scales, such as a slow wave amplitude, may also be found.
  • a correlation between slow wave amplitude and volume of stroke lesion is described, for example, in related provisional application 61/103,287 , and in the co-filed application titled "Measurement of Cerebral Hemodynamic Parameters.”
  • the signals may be smoothed, or averaged over multiple cardiac cycles, or transformed in other ways, and noisy or outlying cardiac cycles may be excluded.
  • the measures may pertain to an effective rise time interval of the signal during a cardiac cycle, defined in various ways, or to an effective fall time interval.
  • the measures may depend on integrals of the signal, for example integrals over an effective rise time or over the whole cardiac cycle, and may depend on weighted integrals, in which, for example, the signal is weighed with a function that falls off smoothly at the limits of the integral, before performing the integration.
  • Obtaining the measures may involve comparing measures found from substantially the same algorithm applied to different signals, for example comparing IPG and PPG signals, or comparing signals based on data pertaining to different sides of the head, or comparing a signal from data pertaining symmetrically to both sides of the head to a signal from data pertaining to only one side of the head.
  • the measures may be dimensionless, not depending on an amplification gain of the signals.
  • ECG data is used in obtaining the measures, for example EGG data is used to calibrate the timing of a feature of the signal relative to the cardiac cycle.
  • FIG. 1 illustrates a cerebral perfusion monitoring system 100, being used to monitor an acute stroke patient 102, optionally continuously, while lying on a bed 104, for example in a hospital.
  • Patient 102 is, for example, an ischemic stroke patient, optionally a patient who has received thrombolytic therapy and is particularly prone to developing a cerebral hemorrhage.
  • patient 102 is an SAH patient, who may be prone to vasospasm.
  • a controller 106 is connected to sensors 108, placed on the patient's head, by cables 110.
  • the controller is, for example, a general-purpose computer, or a specially dedicated circuit.
  • the sensors include electrodes for IPG, and/or PPG sensors, which generate IPG and PPG signals analyzed by controller 106.
  • An example of suitable sensors is shown in more detail below, in FIGS. 3-5 .
  • an ECG device 112 is connected to ECG electrodes placed on the patient's chest, and ECG data is used by controller 106 in analyzing the signals from sensors 108.
  • a display screen 114 displays one or more cerebral hemodynamic parameters or other measures, as a function of time, calculated by controller 106 from the sensor data.
  • Controller 106 activates one or more alert devices 116, for example a flashing light or an audible alarm, to alert medical personnel, if one or more measures of cerebral hemodynamics, calculated by controller 106, change by an amount and in a direction to indicate that the patient requires medical intervention, according to a rule programmed into controller 106.
  • alert device comprises an on-screen icon or similar element that appears, for example, on a display screen at a nurses' station.
  • the on-screen element also provides information about the values of the measures of cerebral hemodynamics that triggered the alert.
  • system 100 may also be used to monitor patients who are ambulatory.
  • FIG. 2 shows a flowchart 200 of a method of monitoring a patient, used by system 100.
  • IPG electrodes and/or PPG sensors are placed on the patient's head.
  • electrodes and/or PPG sensors may also be placed on the patient's neck, for example to measure a signal of blood flow in the carotid artery or another artery in the neck.
  • the electrodes and sensors are optionally placed on the patient after admission to the hospital, and optionally after any initial tests are done, such as perfusion CT or MRI imaging, and after any initial treatment is administered, for example thrombolytic therapy.
  • a cerebral perfusion monitoring system similar to system 100 may also be used to evaluate stroke patients initially, before or upon admission to the hospital, and optionally electrodes and sensors already placed on the patient's head for that purpose are left in place when the patient is transferred to a hospital ward and monitored by system 100. Details of how electrodes and sensors are placed on the patient's head are described below in connection with FIG. 3 .
  • one or more IPG signals from the IPG electrodes, and/or one or more PPG signals from the PPG sensors, are obtained by controller 106, and are processed by the controller at 206. Exemplary details of how this may be done are given below, under the heading "Exemplary methods of analyzing IPG and PPG signals.”
  • Controller 106 calculates from the signals one or more estimated cerebral hemodynamic parameters, such as CBF, CBV, MTT, and TTP, or other measures of cerebral hemodynamics, which can be used to detect medically significant changes in the patient's condition.
  • the inventors have found, in clinical tests, that estimates of regional, hemispheric and global cerebral hemodynamic parameters, calculated from IPG and PPG signals, have correlations of about 0.5 to 0.7 with the same cerebral hemodynamic parameters measured by perfusion CT, across a sample of many different patients, with the parameters varying over a range of a factor of 2 or 3. It is likely that even higher correlations would be found between the estimates and the parameters for a given patient, if the parameters were to change over time.
  • the estimated cerebral hemodynamic parameters or other measures are optionally recorded at 208. This is done, for example, at regular frequent intervals, and the recorded data is used, for example, to create plots of the measures over time, for display screen 114.
  • the current estimates of the parameters or other measures are compared with past values, recorded at 208. If one or more of the measures have changed by too great an amount, either relatively or absolutely, then an alert is optionally given to medical personnel at 212, for example by sounding an alarm.
  • the alert is optionally triggered automatically by controller 106, according to one or more criteria stored in a memory of controller 106, in the form of an algorithm, or a table, or a fuzzy logic condition, etc.
  • the criteria may be personalized for different patients, depending for example on a diagnosis of their condition, or on clinical symptoms, and may be programmable by a physician..
  • an alert may be given if an estimate of CBF, CBV, MTT, or TTP changes by more than 10% of its initial value, or by more than 20%, or by more than 30%, optionally only in a direction that indicates a worsening of the patient's condition, for example a drop in CBF or CBV, or an increase in MTT or TTP.
  • the alert is only given if the change persists for a minimum period, for example for at least 1 minute, or at least 5 minutes, or at least 10 minutes, or at least 20 minutes, or at least 30 minutes. Requiring such a waiting period may reduce false alarms, while still allowing a timely medical response when one is needed.
  • An alert may also be given if a cerebral hemodynamic parameter fails to show an improvement in the patient's condition when it is expected to, for example if CBF fails to increase within one hour, or another period, after thrombolytic therapy is administered.
  • An alert may also be given if a cerebral hemodynamic parameter jumps around in value more than usual, for example with at least twice its usual standard deviation, even without showing a trend in one direction, since this may indicate instability and incipient change in cerebral blood circulation.
  • a change in either direction may be a reason to give an alert.
  • a decrease in CBF may indicate an ischemic stroke
  • an increase in CBF may indicate an increase in blood pressure that could increase the chance of a cerebral hemorrhage.
  • an alert is given even for a change in a measure that indicates an improvement in the patient's condition. For example, if the patient received thrombolytic therapy, then an alert may be given if CBF increases to normal levels, indicating that the blocked artery recanalized due to the therapy. In response, perhaps after verifying the recanalization with other tests, the patient may be moved out of the Intensive Care Unit, or his treatment regimen may be changed to reflect the change in risks and tradeoffs.
  • the threshold of change needed to trigger an alert is smaller if the change occurs over a shorter time.
  • an alert is given whenever a parameter goes beyond an absolute threshold, regardless of the amount change.
  • an alert is given whenever the parameter either goes beyond an absolute threshold or changes by a certain relative or absolute amount. For example, if an estimated value of regional CBF falls below a certain value, such as 20 milliters per 100 grams per minute, this may indicate a need for medical intervention, even if the change in regional CBF was not very great.
  • the values of parameters or changes in parameters that trigger an alert optionally depend on the values of one or more other measures of cerebral hemodynamics, or on other medical parameters that are monitored, such as pulse rate, blood pressure, or body temperature.
  • FIG. 3 shows a combination sensor 300 for a cerebral perfusion monitor system, in place on the head of a patient 302.
  • Another combination sensor 310 optionally a mirror image of sensor 300, is optionally used on the other side the patient's head, and is mostly hidden in FIG. 3 .
  • This sensor design is optionally used for sensors 108 in FIG. 1 .
  • Sensor 300 comprises an IPG electrode structure 304, optionally elliptical in shape, and optionally placed at a corner of the patient's forehead, optionally with an electrically conductive gel to assure good electrical contact with the skin.
  • a PPG sensor 306, optionally circular, is optionally placed on the patient's temple.
  • a cable 308 connects sensor 300 to the controller of the cerebral fusion monitor, for example controller 106 in FIG. 1 .
  • the cable optionally contains eight wires, including two wires used for electrode 304, and four wires used for PPG sensor 306 (two wires each for a light source and a light detector). Two of the wires in the cable are not used in sensor 300, but are included for use in a new design, under development, that will use two IPG electrodes on each side of the head.
  • any other design of IPG electrodes and/or PPG sensors may be used, including any prior art design or off-the-shelf design for IPG electrodes and/or PPG sensors.
  • the system need not use both IPG electrodes and PPG sensors, but optionally only uses one or the other.
  • the combination sensors used on the two sides of the patient's head are optionally placed at positions and orientations that are mirror images of each other, or nearly mirror images of each other, with respect to the bilateral symmetry plane of the head.
  • the two combination sensors are constructed to be mirror images of each other, or nearly mirror images of each other. Using sensors with such symmetry in design and location has the potential advantage that, by comparing measurements that are substantially mirror images of each other, they can be used to detect even small asymmetries in blood circulation in the head, which could be indicative of a stroke.
  • the corresponding electrodes and sensors on the two sides of the head are all placed at locations that are mirror images of each other, to within 2 cm, or 1 cm, or 5 mm, or 2 mm, or 1 mm, or to within whatever precision the head is bilaterally symmetric.
  • the corresponding electrodes and sensors are close enough to being placed in mirror image positions, that any differences in left and right hemisphere cerebral hemodynamic parameters inferred from the IPG and PPG signals from those misplaced sensors and electrodes will be small, by at least a factor of 2, or 5, or 10, or 20, compared to real differences in left and right hemisphere cerebral hemodynamic parameters typically found in ischemic stroke patients, or compared to the ranges in the values of these parameters typically seen among a random sample of ischemic stroke patients.
  • Two measurements are "substantially mirror images of each other" if they are made with corresponding sensors and/or electrodes that are nearly mirror images in their configuration.
  • additional electrodes and/or PPG sensors are used.
  • there may be two electrodes on each side of the head allowing impedance measurements to be made symmetrically, for example locally on each side of the head.
  • impedance measurements are described in the co-fled application titled “Measurement of Cerebral Hemodynamic Parameters,” cited above.
  • an impedance measurement is called “asymmetric” if it is neither symmetric (such as current going from the middle of the forehead to the back of the head) or antisymmetric (such as current going from the right temple to the left temple).
  • FIG. 4 shows electrode structure 304 in more detail.
  • An elliptical ring-shaped current electrode 400 surrounds an elliptical voltage electrode 402.
  • One of the wires in cable 308 connects to the current electrode, which passes current through the head, and one of the wires connects to the voltage electrode, which measures electric potential through a high impedance circuit, and passes very little current.
  • Both are imbedded in an insulating holder 404, and a connector 406 snaps into a connector on the end of able 308, shown in FIG. 3 .
  • a ring-shaped current electrode surrounding a central voltage electrode Some of the potential advantages of using a ring-shaped current electrode surrounding a central voltage electrode are described in two related patent applications cited above, US patent application 10/893,570 , published as US2005/0054939 , and PCT application PCT/IL2005/000632 , published as WO2006/011128 , although in those applications the electrodes are circular rather than elliptical.
  • the ring-shaped current electrode may produce a broader distribution of current, resulting in more current going through the brain and less current going through the scalp, than if a more compact current electrode of the same area were used.
  • the separate high-impedance voltage electrode insulated from the current electrode, may effectively measure the voltage drop across the interior of the skull, with relatively little less contribution from the high impedance skin and skull, than if the same electrode were used for passing current and measuring voltage.
  • the electrodes use a frequency of at least a few kHz, and currents no greater than 2.5 mA. For the test data shown below in the Examples, a frequency of 25 kHz and current of 1 mA or less was used.
  • FIG. 5 shows a more detailed view PPG sensor 306, showing the surface of the sensor that is in contact with the skin.
  • the sensor comprises a red LED 500, and a photodiode 502, imbedded in an opaque holder 504 that keeps out stray light.
  • a suitable LED is, for example, model TF281-200, sold by III-V Compounds.
  • a suitable photodiode is, for example, model TFMD5000R, also sold by III-V Compounds. Red light from the LED scatters from blood in the skin, with relatively little absorption compared to blue or green light.
  • the amplitude of scattered light detected by the photodiode which is optionally further shielded from stray light by a red filter that covers it, increases with increasing blood volume in the skin in the immediate vicinity of the LED and photodiode, and exhibits a characteristic rising and falling pattern over a cardiac cycle.
  • IPG and PPG signals have been found by the inventors to be useful for estimating standard cerebral hemodynamic parameters, as shown by results of a clinical study described below in the Examples. Most of these methods involve analysis of features of the signal that approximately repeat each cardiac cycle. For those features, noise can optionally be reduced by detrending the signal, so that it is always at the same level at the diastolic point of each cycle, by throwing out noisy or unusual cardiac cycles, and by taking a running average of the signals from multiple cardiac cycles in phase with each other, for example taking a running average over 9 cardiac cycles.
  • the result is a relatively low noise signal as a function of cardiac phase, which rises over a relatively short rise time from its minimum value at the diastolic point to a maximum value at the systolic point, and then falls over a longer fall time back to its minimum value at the next diastolic point.
  • Examples of such detrended and averaged IPG and IPG signals are shown below in FIGS. 6A and 6B .
  • the signal used for the analysis need not be a linearly amplified signal coming directly from the IPG electrodes and PPG sensors, but may be nonlinearly distorted in any manner.
  • an effective robust rise time interval may be defined, which may further reduce the effect of noise on the signal analysis.
  • the robust rise time interval begins when the signal is a certain fraction of its total range (maximum minus minimum) above the minimum value, for example 5% or 10% or 15% or 20% above the minimum.
  • the robust rise time interval optionally ends when the signal first reaches a point a certain fraction of its total range below the maximum, for example 5%, 10%, 15%, 20%, 25% or 30% below the maximum.
  • the robust rise time interval is defined as extended from a point 10% above the minimum to a point 20% below the maximum.
  • Characteristics of the signal in an effective rise time interval may be compared to similar characteristics of the signal in an effective fall time interval, which may optionally be defined as any part of the cardiac cycle excluding the effective rise time interval. For example, a ratio of the effective rise time interval to the effective fall time interval may be calculated, or a ratio of the signal integrated over the effective rise time interval to a ratio of the signal over the effective fall time interval. Such ratios are respectively related in a simple way to the effective rise time normalized to the whole cardiac period, and to the signal integrated over the effective rise time, normalized to the signal integrated over the whole cardiac period. The latter measure has been found to be particularly useful for estimating some standard cerebral hemodynamic parameters, as is described below in the Examples.
  • curvature is defined, for example, by first fitting the signal during the rise time interval to a straight line, then fitting the signal during the rise time interval to a parabola, and taking the difference in the cardiac phase, or time, where the two fits cross a level halfway between the minimum and maximum of, the signal. This difference may be normalized to the length of the rise time interval. This definition of curvature may be less sensitive to noise than simply taking the average second derivative of the signal during an effective rise time interval.
  • a measure based on two signals could be the ratio of the effective rise time for the first signal, to the effective rise time defined in the same way, or substantially the same way, for the second signal.
  • the measure for each signal is the normalized signal integrated over the robust rise time described above, then the measure based on both signals could be the ratio of that normalized integral for the first signal, to the normalized integral from the second signal, defined in the same way, or substantially the same way.
  • the two signals could be, for example, an IPG signal and a PPG signal measured on the same side of the head, or an IPG signal measured symmetrically across the head and a PPG signal measured on one side of the head, or two signals of the same modality measured on opposite sides of the head.
  • the measure only uses a signal measured on one side of the head, then the signal may be on the same side of the head as the suspected stroke, based on clinical data such as hemiplegia, or it may be on the opposite side of the head from the suspected stroke. It should be noted that blood circulation patterns on the side of the head opposite to a stroke are also generally affected by the stroke, because, for example, an ischemia on one side of the head may cause greater than normal blood flow on the other side of the head.
  • a procedure is said to comprise comparing two signals when the procedure comprises calculating a difference between the two signals, or calculating a ratio of the two signals, or calculating any quantity that depends on how the two signals are different from each other.
  • composition or method may include additional ingredients and/or steps, but only if the additional ingredients and/or steps do not materially alter the basic and novel characteristics of the claimed composition or method.
  • a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
  • range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
  • IPG and PPG signals were found using up to 1 mA of current, at about 25 kHz.
  • the signals were detrended, setting their minimum for each cardiac cycle to the same level, and in some but not all cases several consecutive cardiac cycles were averaged together, in phase, to reduce noise while retaining the shape of the signal as a function of cardiac cycle phase.
  • a best linear fit and correlation were calculated for the dimensionless measures based on the IPG and PPG signals, and the values of the parameters measured by perfusion CT.
  • Correlations found ranged from approximately 0.5 to 0.7, with values of the parameters generally ranging over a factor of about 2 or 3, or occasionally more, among the different patients in the sample.
  • FIGS. 6A and 6B show plots of IPG and PPG signals for two ischemic stroke patients who participated in the clinical study:
  • FIG. 6A shows a plot 600 of the IPG signal measured across the head, and a plot 602 of the PPG signal measured on the same side of the head as the stroke, for a patient with unusually high global CBV, 5.3 milliliters per 100 grams of tissue, as measured by perfusion CT. The time is given in minutes, and the amplitudes of the signals are in arbitrary units. Noise has been reduced by taking a running average over 9 cardiac cycles, adding up the different cardiac cycles in phase.
  • FIG. 6A shows a plot 600 of the IPG signal measured across the head, and a plot 602 of the PPG signal measured on the same side of the head as the stroke, for a patient with unusually high global CBV, 5.3 milliliters per 100 grams of tissue, as measured by perfusion CT. The time is given in minutes, and the amplitudes of the signals are in arbitrary units. Noise has been reduced
  • FIG. 6B shows a plot 604 of an IPG signal, and a plot 606 of a PPG signal, measured in the same way for a patient with unusually low global CBV, only 2.1 milliliters per 100 grams of tissue.
  • the signals, especially the IPG signal are visibly very different in the two patients, reflecting the large differences in their global CBV.
  • the differences may be quantified by taking the normalized integral of the signal over a robust rise time, as described above. This quantity is 0.08 for the signal in plot 600, because the signal rises very quickly; 0.14 for the signal in plot 602; 0.21 for the signal in plot 604, which rises much more slowly than the signal in plot 600; an 0.19 for the signal in plot 606.

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Claims (26)

  1. System zur Überwachung eines Patienten mit akutem Schlaganfall, Folgendes umfassend:
    mindestens zwei IPG-Sensoren (108), die dafür konfiguriert sind, Strom von einer Stromquelle durch das Herz eines Patienten zu leiten, um die Impedanz zu messen,
    einen Controller (106), der für Folgendes konfiguriert ist:
    a) Erzielen von Signalen der Impedanzplethysmografie (IPG) von den mindestens zwei IPG-Sensoren (108) mindestens sechs Stunden lang mindestens einmal die Stunde,
    b) Verarbeiten der IPG-Signale, um erste und zweite Messwerte von zerebralen Hämodynamiken des Patienten zu erzielen,
    c) Finden eines Messwertes, der auf dem Vergleich des ersten und des zweiten Messwertes basiert, und
    d) Anwenden einer Regel zur Alarmierung oder Nichtalarmierung des medizinischen Personals, basierend auf Werten und/oder Umfang der Veränderung und/oder Richtung und Geschwindigkeit der Veränderung des Messwertes, der auf dem Vergleich des ersten und des zweiten Messwertes basiert,
    dadurch gekennzeichnet, dass der Controller (106) dafür konfiguriert ist, den gleichen oder im Wesentlichen gleichen Algorithmus auf die IPG-Signale anzuwenden, um den ersten und den zweiten Messwert zu erzielen, und dass der erste und der zweite Messwert jeweils eine effektive Anstiegszeit eines Herzzyklus des entsprechenden Signals oder jeweils ein Integral des entsprechenden Signals über eine effektive Anstiegszeit verwenden.
  2. System nach Anspruch 1, wobei der Controller (106) dafür konfiguriert ist, den ersten und den zweiten Messwert zu finden und die Regel automatisch, ohne menschliches Eingreifen anzuwenden.
  3. System nach einem der vorhergehenden Ansprüche, wobei der Patient ein ischämischer Schlaganfallpatient ist.
  4. System nach einem der Ansprüche 1 bis 2, wobei der Patient ein Subarachnoidalblutungs-(SAB)-Patient ist.
  5. System nach einem der vorhergehenden Ansprüche, wobei die Messwerte eine Schätzung eines oder mehrerer globaler, hemisphärischer oder lokaler Messwerte der zerebralen Durchblutung (CBF), des zerebralen Blutvolumens (CBV), der mittleren Durchgangszeit (MTT) und der Zeit bis zum Peak (TTP) und mathematischer Funktionen der genannten Parameter einzeln oder in einer beliebigen Kombination umfassen.
  6. System nach einem der vorhergehenden Ansprüche, wobei die Signale mindestens ein erstes Signal umfassen, das aus einer Messung vorrangig der linken Seite des Kopfes erzielt wird, und ein zweites Signal, das aus einer Messung vorrangig der rechten Seite des Kopfes erzielt wird, die im Wesentlichen ein Spiegelbild der ersten Messung ist, und der Controller ferner dafür konfiguriert ist, das erste und das zweite Signal zu vergleichen.
  7. System nach einem der vorhergehenden Ansprüche, wobei die Signale mindestens ein Signal umfassend, das aus einer Impedanzmessung erzielt wird, die in Bezug auf die beidseitige Symmetrieebene des Patientenkopfes im Wesentlichen symmetrisch oder gegensymmetrisch vorgenommen wird.
  8. System nach einem der vorhergehenden Ansprüche, wobei die Zeitspanne des effektiven Anstiegs beginnt, wenn das Signal erstmalig einen feststehenden Prozentsatz des vollen Signalbereichs erreicht, der über einem Minimalwert des Signals liegt.
  9. System nach einem der vorhergehenden Ansprüche, wobei die Zeitspanne des effektiven Anstiegs endet, wenn das Signal erstmalig einen feststehenden Prozentsatz des vollen Signalbereichs erreicht, der unter einem Maximalwert des Signals liegt.
  10. System nach einem der vorhergehenden Ansprüche, wobei die Zeitspanne des effektiven Anstiegs bei einem maximalen Signalgefälle oder am ersten Wendepunkt des Signals mit dritter positiver Ableitung oder bei einem ersten örtlichen Maximum des Signals nach dem Beginn der Zeitspanne des effektiven Anstiegs endet.
  11. System nach einem der vorhergehenden Ansprüche, wobei der Controller (106) ferner dafür konfiguriert ist, ein Integral des Signals über die Zeitspanne des effektiven Anstiegs zu finden.
  12. System nach Anspruch 11, wobei der Controller (106) ferner dafür konfiguriert ist, das Integral des Signals über die Zeitspanne des effektiven Anstiegs mit einem Integral des Signals über eine Zeitspanne des effektiven Abfalls eines Herzzyklus oder über einen gesamten Herzzyklus zu vergleichen.
  13. System nach einem der vorhergehenden Ansprüche, wobei der Controller (106) ferner dafür konfiguriert ist, eine Krümmung des Signals während der Zeitspanne des effektiven Anstiegs zu finden.
  14. System nach einem der vorhergehenden Ansprüche, wobei der Controller (106) ferner dafür konfiguriert ist, ein Signal zu normalisieren, um einen Messwert zu erzielen, der nicht von einem Grad der Verstärkung des Signals abhängt.
  15. System nach einem der vorhergehenden Ansprüche, wobei der Controller (106) ferner dafür konfiguriert ist, eine Zeitspanne zu einer Herzzyklusspanne zu normalisieren.
  16. System nach einem der vorhergehenden Ansprüche, wobei der Controller (106) ferner dafür konfiguriert ist, ein Elektrokardiogramm-(EKG)-Signal des Patienten zu empfangen und das EKG-Signal zu verwenden, um den Zeitpunkt eines Merkmals eines IPG in einem Herzzyklus zu kalibrieren.
  17. System nach einem der vorhergehenden Ansprüche, wobei die Messwerte eine Schätzung der zerebralen Durchblutung umfassen und medizinisches Personal alarmiert wird, wenn die Schätzung der zerebralen Durchblutung um ein festgelegtes relatives Maß fällt, das mindestens 10 % eines Anfangswertes der Schätzung der zerebralen Durchblutung ausmacht.
  18. System nach Anspruch 17, wobei das festgelegte relative Maß nicht mehr als 30 % eines Anfangswertes der Schätzung der zerebralen Durchblutung beträgt.
  19. System nach einem der vorhergehenden Ansprüche, wobei die Messwerte eine Schätzung der zerebralen Durchblutung umfassen und medizinisches Personal alarmiert wird, wenn die Schätzung der zerebralen Durchblutung um ein festgelegtes relatives oder absolutes Maß zunimmt.
  20. System nach einem der vorhergehenden Ansprüche, wobei die Signale ein Signal umfassen, das aus einer Messung erzielt wird, die vorrangig an einer Seite des Kopfes vorgenommen wird, und der Controller (106) ferner dafür konfiguriert ist, mindestens das Signal zu verwenden, um einen Messwert zu finden, der eine Schätzung eines hemisphärischen oder regionalen zerebralen hämodynamischen Parameters an derselben Seite des Kopfes oder an der gegenüberliegenden Seite des Kopfes ist.
  21. System nach Ansprüch 20, wobei der hemisphärische oder regionale zerebrale hämodynamische Parameter an einer Seite des Kopfes liegt, in der ein klinischer Nachweis einen aufgetretenen Schlaganfall anzeigt.
  22. System nach einem der vorhergehenden Ansprüche, wobei ein erstes der Signale aus einer Messung erzielt wird, die am Kopf im Verhältnis zur beidseitigen Symmetrieebene im Wesentlichen symmetrisch vorgenommen wird, und ein zweites der Signale aus einer Messung erzielt wird, die vorrangig an einer Seite des Kopfes vorgenommen wird.
  23. System nach einem der vorhergehenden Ansprüche, wobei beide Signale aus Messungen erzielt werden, die vorrangig an derselben Seite des Kopfes vorgenommen werden.
  24. System nach einem der vorhergehenden Ansprüche, wobei das Verarbeiten des einen oder der mehreren Signale das Finden einer durchschnittlichen zweiten Ableitung des Signals während einer Zeitspanne des effektiven Anstiegs umfasst.
  25. System nach einem der vorhergehenden Ansprüche, ferner die Stromquelle umfassend.
  26. Verfahren zum Überwachen eines Patienten mit akutem Schlaganfall, Folgendes umfassend:
    a) Erzielen von Signalen der Impedanzplethysmografie (IPG) von mindestens zwei IPG-Sensoren (108), die dafür konfiguriert sind, Strom von einer Stromquelle durch das Herz eines Patienten zu leiten, mindestens sechs Stunden lang mindestens einmal die Stunde,
    b) Anwenden eines gleichen oder im Wesentlichen gleichen Algorithmus auf die IPG-Signale, um einen ersten und einen zweiten Messwert zerebraler Hämodynamiken des Patienten zu erzielen,
    c) Finden eines Messwertes, der auf dem Vergleich des ersten und des zweiten Messwertes basiert, und
    d) Anwenden einer Regel zur Alarmierung oder Nichtalarmierung des medizinischen Personals, basierend auf Werten und/oder Umfang der Veränderung und/oder Richtung und Geschwindigkeit der Veränderung des Messwertes, der auf dem Vergleich des ersten und des zweiten Messwertes basiert,
    wobei der erste und der zweite Messwert jeweils eine effektive Anstiegszeit eines Herzzyklus des entsprechenden Signals oder jeweils ein Integral des entsprechenden Signals über eine effektive Anstiegszeit verwenden.
EP09745115.7A 2008-10-07 2009-10-07 Überwachung von patienten mit akutem schlaganfall Not-in-force EP2344034B1 (de)

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PCT/IB2009/054392 WO2010041205A2 (en) 2008-10-07 2009-10-07 Monitoring of acute stroke patients

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EP09748147.7A Not-in-force EP2344033B1 (de) 2008-10-07 2009-10-07 Diagnose von akuten schlaganfällen
EP15187494.8A Withdrawn EP3031395A1 (de) 2008-10-07 2009-10-07 Überwachung von patienten mit akutem schlaganfall
EP09743915A Withdrawn EP2346403A2 (de) 2008-10-07 2009-10-07 Messung von zerebralen hämodynamischen parametern
EP09745115.7A Not-in-force EP2344034B1 (de) 2008-10-07 2009-10-07 Überwachung von patienten mit akutem schlaganfall

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EP15187494.8A Withdrawn EP3031395A1 (de) 2008-10-07 2009-10-07 Überwachung von patienten mit akutem schlaganfall
EP09743915A Withdrawn EP2346403A2 (de) 2008-10-07 2009-10-07 Messung von zerebralen hämodynamischen parametern

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